Genetic Biomarkers Associated With Child Language Development in Taiwan (II)

NCT05510570 | Completed DMC

• 1 other identifier: 202002413A3
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

A study of the relation between genetic biomarkers and child language development in Taiwan.

Conditions

Child Language

Keywords

language development; gene; whole-exome sequencing; body function and body structure; quality of Life

Outcome Measures

Primary Outcomes (9)

• Scores of cognitive function 1

  Bayley Scales of Infant and Toddler Development (Scores from 0 to 140, higher scores mean a better outcome.)

  baseline

• Scores of cognitive function (2 y/o to 6 y/o)

  Wechsler Preschool and Primary Scale of Intelligence (Scores from 0 to 200, higher scores mean a better outcome.)

  baseline

• Scores of cognitive function (6 y/o to 16 y/o)

  Wechsler Intelligence Scale for Children (Scores from 0 to 200, higher scores mean a better outcome.)

  baseline

• Scores of cognitive function 3

  Test of Nonverbal Intelligence-Fourth Edition (Scores from 0 to 60, higher scores mean a better outcome.)

  baseline

• Scores of language function 1

  Peabody Picture Vocabulary Test-Revised (Scores from 0 to 124, higher scores mean a better outcome.)

  baseline

• Scores of language function 2

  Preschool Language Impaired Scale(PLS)/Language Impaired Scale(LS) (PLS: Scores from 0 to 65, higher scores mean a better outcome. LS: Scores from 0 to 73, higher scores mean a better outcome.)

  baseline

• Scores of general development

  Comprehensive Developmental Inventory for Infants and Toddlers (Higher scores mean a better outcome.) Applied for children aged 3-71 months. Assessing areas: Cognition, language, motor, social, and self-care skills. Every item is scored 0 or 1, indicating whether the child 'fails' or 'passess' that item.

  baseline

• Gene test 1

  Microarray (Use Axiom Genome-Wide TWB 2.0 Array Plate (TWB 2.0) to analyze SNPs of disease-related biomarkers.)

  baseline

• Gene test 2

  Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)

  baseline

Secondary Outcomes (4)

• Scores of participation(2-5 y/o)

  baseline

• Scores of participation(>6 y/o)

  baseline

• Scores of activities

  baseline

• Scores of quality of life

  baseline

Study Arms (2)

control

healthy child

experimental

patients with language disorder

Genetic: The research does not require interventions

Interventions

The research does not require interventions GENETIC

We use Whole-exome sequence (WES) to analyze if there is any gene mutations for DLD(developmental language disorder) children.

experimental

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Control and experimental groups

You may qualify if:

• Age 2-18 y/o
• Agree to sign informed consent

You may not qualify if:

• Central nervous system disease
• Neuromuscular Disorders
• Congenital Abnormality
• Genetic Disease
• Dysesthesia
• Hearing Impairment
• Patients with Language Disorder
• Age 2-18 y/o
• Agree to sign informed consent
• Hearing Impairment
• His or her child participated in this study, and gene abnormality was found.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memoria Hospital

Taoyuan District, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

samples with DNA

Study Officials

• Chia-Ling Chen, MD, PhD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: August 2, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 28, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)